Recalls / —

—#42034

Product

Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS

FDA product code

FBK — Endoscopic Injection Needle, Gastroenterology-Urology

Device class

Class 2

Medical specialty

Gastroenterology, Urology

Affected lot / code info

All lots codes

Why it was recalled

Incorrect implantation may cause serious health complications

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific issued Recall notification by FED'X on 9/23/05 as follows Customers/ Hospital Account / Distributors: A Recall Notification Package will be sent to the risk manager of each hospital account via FedEx. This package contains a Recall Notification Letter, instructions on how to return product, a Recall Verification Form, and a Physician Letter that provides recommendations of patient follow-up. . Physicians Trained in the Enteryx Procedure: All physicians that attended the physician training program sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided to assist in their communication to the patient. Patient Letter / Patient Phone Script: A letter and phone script, from the physician to the patient, will be provided to the physician to assist in the physician's communication to patient. The letter informs the patient of the recall and asks them to contact their physician and the Patient Phone Script provides a template to initiate a discussion with the patient. Physicians Participating in Post Approval Studies: All physicians that are participating in post approval studies will be sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone script will be provided to assist in their communication to the patient. Internal Review Boards (IRBs): All IRBs that are participating in post approval studies will be sent, via FedEx, a IRB Letter and the Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided. Boston Scientific has posted the recall to their website:http://www

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern

Nationwide :

Timeline

Recall initiated

2005-09-23

Posted by FDA

2005-10-28

Terminated

2006-10-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #42034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.